Apparatus for extracorporeal treatment of blood and method of control of a blood-warming device in an extracorporeal blood treatment apparatus

ABSTRACT

An extracorporeal blood treatment apparatus ( 1 ) comprising a control unit ( 10 ) connectable to a blood warming device ( 200 ). The apparatus ( 1 ) comprises: an extracorporeal blood circuit ( 100 ) and at least one infusion line ( 15, 21, 25 ) connected to the extracorporeal blood circuit ( 100 ). A control unit ( 10 ) is configured to execute the following procedure: receiving a first value representative of a desired blood temperature (T des ) at an end ( 70 ) of a blood return line ( 7 ) configured to be connected to a venous vascular access of a patient (P); receiving at least a first signal relating to at least a flow rate (Q PBP , Q REP1 , Q REP2 ) of an infusion fluid in the at least one infusion line ( 15, 21, 25 ); calculating a set point value of an operating parameter (T OUT ; P w ) to be imposed on the warming device ( 200 ) configured to heat a blood heating zone (H) of the extracorporeal blood circuit ( 100 ) in order to maintain the desired blood temperature (T des ) at the end ( 70 ) of the blood return line ( 7 ). The set point is calculated based on input parameters comprising: at least the first value representative of the desired blood temperature (T des ) and at least one selected in the group of: the first signal (Q REP1 , Q PBP , Q REP2 ) and a second value representative of a temperature (T REP1 , T PBP , T REP2 ) of the at least one infusion fluid in the at least one infusion line ( 15, 21, 25 ).

This application is a continuation application of U.S. application Ser.No. 15/510,302 filed Mar. 10, 2017, which is a U.S. National StageApplication of International Application No. PCT/EP2015/069497, filedAug. 26, 2015, which was published in English on Mar. 24, 2016 asInternational Publication No. WO 2016/041745 A1. InternationalApplication No. PCT/EP2015/069497 claims priority to EuropeanApplication No. 14184700.4 filed Sep. 15, 2014. A certified copy ofEuropean Application No. 14184700.4 filed Sep. 15, 2014 was provided in,and is available in, U.S. patent application Ser. No. 15/510,302 filedMar. 10, 2017 for which certified copy is available in PAIR.

The present invention relates to an apparatus for extracorporealtreatment of blood. In accordance with certain aspects, theextracorporeal treatment apparatus according to the invention iscombined with, or comprises, a blood-warming device. The invention alsoconcerns a method of control of a blood-warming device wherein theblood-warming device may be part of the extracorporeal blood treatmentapparatus or may be a separate device, which is in communication withthe extracorporeal blood treatment apparatus.

Extracorporeal blood treatment involves removing blood from a patient,treating the blood externally to the patient, and returning the treatedblood to the patient. Extracorporeal blood treatment is typically usedto extract undesirable matter or molecules from the patient's bloodand/or add desirable matter or molecules to the blood. Extracorporealblood treatment is used with patients unable to effectively removematter from their blood, such as when a patient has suffered temporaryor permanent kidney failure. These patients and other patients mayundergo extracorporeal blood treatment to add or remove matter to theirblood, to maintain an acid/base balance or to remove excess body fluids,for example.

Extracorporeal blood treatment is typically accomplished by removing theblood from the patient in e.g. a continuous flow, introducing the bloodinto a primary chamber, also referred to as blood chamber, of atreatment unit (such as a dialyzer or an hemofilter) where the blood isallowed to flow past a semipermeable membrane. The semipermeablemembrane selectively allows matter in the blood to cross the membranefrom the primary chamber into a secondary chamber and also selectivelyallows matter in the secondary chamber to cross the membrane into theblood in the primary chamber, depending on the type of treatment.

A number of different types of extracorporeal blood treatments may beperformed. In an ultrafiltration (UF) treatment, undesirable fluid isremoved from the blood by convection across the membrane into thesecondary chamber. In a hemofiltration (HF) treatment, the blood flowspast the semipermeable membrane as in UF (where waste and undesirablefluid are removed) and desirable matter is added to the blood, typicallyby dispensing a fluid into the blood either before and/or after itpasses through the treatment unit and before it is returned to thepatient. In a hemodialysis (HD) treatment, a secondary fluid containingdesirable matter is introduced into the secondary chamber of thetreatment unit. Undesirable matter from the blood crosses thesemipermeable membrane into the secondary fluid by diffusion anddesirable matter from the secondary fluid crosses the membrane into theblood. In a hemodiafiltration (HDF) treatment, blood and secondary fluidexchange matter as in HD, and, in addition, matter is added to theblood, typically by dispensing a fluid into the treated blood (infusion)either before and/or after it passes through the treatment unit andbefore its return to the patient as in HF.

During extracorporeal blood treatment therapies, the patient may loosesignificant amount of heat due to infusion fluids having lowertemperature than blood, due to fluid exchange across the membrane of thetreatment unit, and due to heat lost to the atmosphere. Asextracorporeal blood treatments may last from several hours up toseveral days, the patient is put at risk of hypothermia in case nopreventive measures are taken. This risk is, for example, present bothin the case of relatively short treatments with high volume exchange,like chronic HD or HDF, and in the case of low volume but continuoustherapies like continuous renal replacement therapy (CRRT) (used in e.g.acute HD). Furthermore, the risk of hypothermia is even more problematicin case of treatments applied to low body weight patients, such aschildren.

Blood cooling due to fluid exchange (treatment and/or infusion fluids)is usually more important than heat losses to atmosphere in the completeextracorporeal blood circuit.

In order to prevent hypothermia during extracorporeal blood treatmentseveral solutions have been developed in the past.

In accordance with a first known solution described in U.S. Pat. No.4,894,164, the treatment fluid used for dialyzing blood is warmed-up inorder to try to balance the heat lost by the blood circulating in theextracorporeal blood circuit. This solution presents however a number ofdrawbacks. Warming of treatment or infusion fluids requires managingfluid degassing, and may lead to precipitation problems when usingbicarbonate solutions. Additionally, fluid warming requires multiplyingthe heating and degassing means on each fluid circuit when differentfluid compositions are or have to be used (e.g. citrateanticoagulation).

In accordance with a second known solution, and in order to solve theabove problems, blood warmers acting on the bloodline, and capable ofdirectly warming blood, have been used. Blood warmers directly acting onthe extracorporeal blood circuit have several benefits with respect towarming the treatment or the infusion fluid: in fact, blood warmers maybe used with all types of therapies and do not cause problems ofprecipitation of solutes. Furthermore, as blood warmers act directly onthe extracorporeal blood circuit it may be easier to control bloodtemperature. It should be noted that the blood warmers currently in themarketplace are formed by a device separate from the extracorporealblood treatment apparatus and operating independently from this latter.

It is an object of the present invention according to at least someembodiments to improve management of the blood warming step in order toimprove balancing of the cooling effects due in particular to infusionof fluids.

It is an object of the present invention according to at least someembodiments to render available an extracorporeal blood treatmentapparatus capable of facilitating the control of patient temperature inextracorporeal blood circuits including infusion of fluids, inparticular downstream of the warming device.

It is an object of the present invention according to at least someembodiments to provide an extracorporeal blood treatment apparatus andmethod capable of increasing patient safety.

It is an object of the present invention according to at least someembodiments to render available an extracorporeal blood treatmentapparatus and method capable of efficiently cooperating with a warmingdevice and providing improved management during the blood-warming step.

SUMMARY

Preferably at least one of the above objects is substantially reached byan apparatus or by an assembly according to one or more of the appendedclaims.

Preferably at least one of the above objects is substantially reached bya method according to one or more of below described aspects.

An apparatus and assemblies for the extracorporeal treatment of bloodaccording to aspects of the invention are here below described.

A 1^(st) aspect relates to extracorporeal blood treatment apparatus,comprising:

-   an extracorporeal blood circuit having a treatment unit, a blood    withdrawal line connected to a blood inlet of the treatment unit,    and a blood return line connected to a blood outlet of the treatment    unit;-   a blood pump configured for controlling blood flow rate flowing    through at least one of said blood withdrawal line and blood return    line;-   at least one infusion line connected to the extracorporeal blood    circuit;-   a control unit configured to execute the following procedure:    receiving a first value representative of a desired blood    temperature at an end of the blood return line configured to be    connected to a venous vascular access of a patient;-   receiving at least a first signal relating to at least a flow rate    of an infusion fluid in said at least one infusion line;-   calculating a set point value of an operating parameter to be    imposed on a warming device configured to heat a blood heating zone    of the extracorporeal blood circuit in order to maintain said    desired blood temperature at said end of the blood return line;-   wherein the set point is calculated based on input parameters    comprising:-   at least the first value representative of the desired blood    temperature and-   at least one selected in the group of:-   the first signal and-   a second value representative of a temperature of said at least one    infusion fluid in said at least one infusion line.

The invention allows to control the temperature of the blood flowingback into the patient and to keep it at the desired value withoutrequiring any sensor placed at the end of the blood return line. In thisway the overall structure of the apparatus and/or of the warming devicedoes not require additional hardware with respect to the hardwarealready present on known apparatuses.

Indeed, the desired blood temperature is a value defined without the aidof any sensor of the apparatus but a pre-defined value for instancechosen by the physician. Such a desired blood temperature may be enteredinto the control unit of said apparatus though input devices (forinstance a user interface). The desired blood temperature may be such toavoid any risk of hypothermia of the patient under treatment. Thedesired blood temperature may be substantially equal to the coretemperature of the patient. The desired blood temperature may be a fixedvalue (by way of example such value may be 37.5° C.)

In a 2^(nd) aspect according to the previous aspect, the control unit isfurther configured to:

-   receive a second signal relating to the blood flow rate in the    extracorporeal blood circuit;-   wherein the input parameters comprise said second signal.

In a 3^(rd) aspect according to anyone of the previous aspects, the atleast one infusion line is connected to the extracorporeal blood circuitat a junction point which is positioned downstream of the blood heatingzone, in particular between the blood heating zone and said end of theblood return line.

In a 4^(th) aspect according to any one of the preceding aspects, the atleast one infusion line comprises a post-infusion line directlyconnected to said blood return line.

The invention allows to keep the desired temperature of blood flowingback into the patient also if, as it usually happens, the most importantcooling effect is due to infusion of fluid/s downstream of the warmingdevice.

In a 5^(th) aspect according to any one of the preceding aspects, the atleast one infusion line comprises a pre-infusion line directly connectedto said blood withdrawal line.

In a 6^(th) aspect according to the preceding aspect, the pre-infusionline comprises a pre-blood pump infusion line directly connected to saidblood withdrawal line upstream of said blood pump.

In a 7^(th) aspect according to the preceding aspect, the pre-infusionline is directly connected to said blood withdrawal line downstream ofsaid blood pump.

The invention allows to keep the desired temperature of blood flowingback into the patient also in presence of a plurality of infusion linesdownstream and/or upstream of the warming device.

In a 8^(th) aspect according to any one of the preceding aspects, saidsecond value is a set or a measured value.

In a 9^(th) aspect according to any one of the preceding aspects, thesecond value is set by an operator via a user interface connected to thecontrol unit.

In a 10^(th) aspect according to any one of the preceding aspects, saidsecond value is representative of a room temperature where the apparatusis located.

The temperature of infusion fluids (usually contained in bags) may betaken equal to the room temperature (measured by means of a temperaturesensor) or may be assumed equal to the Standard Temperature (25° C.,SATP—standard ambient temperature and pressure).

In a 11^(th) aspect according to the preceding aspect, the apparatuscomprises a room temperature sensor configured to measure the roomtemperature and to issue a corresponding measurement signal to thecontrol unit.

In a 12^(th) aspect according to any one of the preceding aspects from1^(st) to 7^(th), the apparatus comprises a fluid temperature sensor onsaid at least one infusion line, wherein the second value is a measuredvalue detected by said fluid temperature sensor.

In a 13^(th) aspect according to the preceding aspect, the fluidtemperature sensor is connected to the control unit and the control unitis configured to receive said measured value from said fluid temperaturesensor.

In this case, the second value is more accurate thanks to the measuredtemperature of infusion fluid/s.

In a 14^(th) aspect according to any one of the preceding aspects, theapparatus comprises a treatment fluid line connected to the treatmentunit.

In a 15^(th) aspect according to the preceding aspect, the control unitis further configured to:

-   receive a third signal relating to a flow rate of a treatment fluid    in said treatment fluid line;-   receive a third value representative of a temperature of said    treatment fluid in said treatment fluid line;-   wherein the input parameters also comprise the third signal and the    third value representative of the temperature of the treatment    fluid.

In a 16^(th) aspect according to the preceding aspect, calculation ofset point is performed taking into account characteristics of a filterof the treatment unit.

In a 17^(th) aspect according to the preceding aspect, the apparatuscomprises a plurality of infusion lines connected to the extracorporealblood circuit, the control unit being configured for:

-   receiving a plurality of first signals, each relating to the flow    rate of infusion fluid in a respective infusion line;-   calculating said set point based on the following input parameters:-   the first signal/s and-   the temperature/s of the infusion fluid in the infusion line/s    connected to the extracorporeal blood circuit downstream of the    blood heating zone.

In a 18^(th) aspect according to any one of the preceding aspects from15^(th) to 17^(th), the blood heating zone is a portion of theextracorporeal blood circuit located in the blood withdrawal line, andwherein the control unit is configured for calculating said set pointalso based on the third signal and on the temperature of the treatmentfluid.

In a 19^(th) aspect according to any one of the preceding aspects from15^(th) to 18^(th) the set point is calculated based on the followinginput parameters:

-   the first signal/s and on the temperature/s of the infusion fluid in    the infusion line/s connected to the extracorporeal blood circuit    upstream and downstream the blood heating zone and-   the third signal and the temperature of the treatment fluid.

In a 20^(th) aspect according to any one of the preceding aspects, theoperating parameter is representative of the blood temperature at anoutlet of the blood heating zone.

In a 21^(st) aspect according to any one of the preceding aspects from1^(st) to 19^(th), the operating parameter is a temperature of a part ofthe warming device, such as the temperature of a heating plate.

In a 22^(nd) aspect according to any one of the preceding aspects from1^(st) to 19^(th), the operating parameter is the electric powersupplied to a heating unit of the warming device.

In a 23^(rd) aspect according to any one of the preceding aspects, theblood heating zone is a portion of the extracorporeal blood circuitpositioned on the blood return line.

In a 24^(th) aspect according to any one of the preceding aspects from1^(st) to 22^(nd), the blood heating zone is a portion of theextracorporeal blood circuit positioned on blood withdrawal line.

In a 25^(th) aspect according to one of the preceding aspects from1^(st) to 22^(nd), the blood heating zone is located at the treatmentunit.

In a 26^(th) aspect according to one of the preceding aspects from1^(st) to 14^(th) and from 20^(th) to 22^(nd) and 25^(th), the warmingdevice is located on the treatment fluid line. In this case, the warmingdevice directly heats the treatment fluid and the treatment fluid heatsthe blood at the treatment unit.

In a 27^(th) aspect according to one of the preceding aspects from1^(st) to 22^(nd) and 24^(th), the warming device is located on theblood withdrawal line.

In a 28^(th) aspect according to one of the preceding aspects from1^(st) to 23^(rd), the warming device is located on the blood returnline.

In a 29^(th) aspect according to one of the preceding aspects from27^(th) to 28^(th), the warming device is configured to heat the bloodheating zone.

In a 30^(th) aspect according to one of the preceding aspects from25^(th) to 26^(th), the warming device is configured to heat thetreatment fluid line.

In a 31^(st) aspect according to one of the preceding aspects, theapparatus comprises the warming device.

In a 32^(nd) aspect according to one of the preceding aspects from1^(st) to 30^(th), the blood warming device is separate from theapparatus.

In a 33^(rd) aspect according to one of the preceding aspects, thewarming device is connected to the control unit and the control unit isconfigured to generate a control signal comprising a command directed toimpose to the warming device to operate with said operating parameter atthe calculated set point.

In a 34^(th) aspect according to the 32^(nd) aspects, the control unitof the extracorporeal blood treatment apparatus is configured tocommunicate by means of a communication device (such as a display) thecalculated set point value to an operator and the control system of thewarming device is configured to receive said calculated set point value(by way of example entered by the operator by means of a user interfacewhich may comprise buttons or knobs or a keyboard) and to impose to thewarming device to operate with said operating parameter at thecalculated set point.

In a 35^(th) aspect according to one of the preceding aspects, theapparatus comprises a fluid temperature sensor configured to measure ablood temperature at the outlet of the blood heating zone and to issue acorresponding measurement signal.

In a 36^(th) aspect according to the preceding aspect, the operatingparameter is the blood temperature at the outlet of the blood heatingzone.

In a 37^(th) aspect according to the preceding aspect, the control unitis configured to perform a feedback control on the warming device, saidfeedback control comprising regulating electric power fed to a heatingunit of the warming device based on a said measurement signal and onsaid calculated set point.

In a 38^(th) aspect according to one of the preceding aspects, theapparatus comprises a communication device.

In a 39^(th) aspect according to the preceding aspect, the control unitis configured to communicate by means of said communication device theset point to an operator.

In a 40^(th) aspect according to one of the preceding aspects, thecontrol unit is configured to recalculate the set point eitherperiodically or when a change to at least one of the input parametersoccurs.

In a 41^(st) aspect according to one of the preceding aspects, thecontrol unit is configured to compare the calculated set point with amaximum set point and to communicate said maximum set point by means ofthe communication device if the calculated set point exceeds the maximumset point.

In a 42^(nd) aspect according to one of the preceding aspects, thecontrol unit is configured to compare the calculated set point with amaximum set point and to impose to the warming device to operate at themaximum set point if the calculated set point exceeds the maximum setpoint.

In a 43^(rd) aspect according to one of the preceding aspects, thecontrol unit is configured to send a warning message about the patientover-warming risk by means of the communication device when infusion isstopped for a preset amount of time.

In a 44^(th) aspect according to one of the preceding aspects, thecontrol unit is configured to receive the patient weight and wherein theemission of the warning message also depends on said patient weight. Inan aspect, the emission of the warning message also depends on the flowrate of blood. In an aspect, the emission of the warning message alsodepends on the ratio between the blood flow rate and the patient weight.

In a 45^(th) aspect according to one of the preceding aspects, thecontrol unit receives or stores a function interrelating said set pointwith said input parameters and wherein calculation of the set point isperformed using said function.

A 46^(th) aspect concerns an assembly including the extracorporeal bloodtreatment apparatus and the warming device, wherein the warming deviceand the extracorporeal blood treatment apparatus are separate.

In a 47^(th) aspect according to the preceding aspect, the warmingdevice comprises a respective control system separate from the apparatuscontrol unit.

In a 48^(th) aspect according to the preceding aspect, the controlsystem of the warming device is configured to receive from the controlunit a control signal comprising a command directed to impose to thewarming device to operate with said operating parameter at thecalculated set point imposed by said command.

In a 49^(th) aspect according to the preceding aspects from 46^(th) to48^(th), the warming device comprises a fluid temperature sensorconfigured to measure a blood temperature at the outlet of the bloodheating zone and to issue a corresponding measurement signal.

In a 50^(th) aspect according to the preceding aspect from 46^(th) to49^(th), the operating parameter is the blood temperature at the outletof the blood heating zone.

In a 51^(st) aspect according to the preceding aspect from 46^(th) to50^(th), the control system is configured to perform a feedback control,said feedback control comprising regulating electric power fed to aheating unit of the warming device based on a said measurement signaland on said calculated set point.

A 52^(nd) aspect concerns a method of control a warming device in anextracorporeal blood treatment apparatus,

-   wherein said apparatus comprises:-   an extracorporeal blood circuit having a treatment unit, a blood    withdrawal line connected to a blood inlet of the treatment unit,    and a blood return line connected to a blood outlet of the treatment    unit;-   a blood pump configured for controlling blood flow rate flowing    through at least one of said blood withdrawal line and blood return    line;-   at least one infusion line connected to the extracorporeal blood    circuit;-   wherein the method comprises:-   calculating a set point value of an operating parameter to be    imposed on a warming device configured to heat a blood heating zone    of the extracorporeal blood circuit in order to maintain a desired    blood temperature at an end of the blood return line configured to    be connected to a venous vascular access of a patient;-   wherein the set point is calculated based on input parameters    comprising:-   at least a first value representative of the desired blood    temperature and at least one selected in the group of:-   a first signal relating to at least a flow rate of an infusion fluid    in said at least one infusion line and-   a second value representative of a temperature of said at least one    infusion fluid in said at least one infusion line.

In a 53^(rd) aspect according to one of the preceding aspects, the setpoint is calculated based also on blood properties (such as blooddensity, specific heat, hematocrit and/or total protein concentration).

In a 54^(th) aspect according to one of the preceding aspects, the setpoint is calculated based also on heat losses to atmosphere in theextracorporeal blood circuit downstream of the blood heating zone.

DESCRIPTION OF THE DRAWINGS

Aspects of the invention are shown in the attached drawings, which areprovided by way of non-limiting example, wherein:

FIG. 1 schematically shows a first example of a blood treatmentapparatus;

FIG. 2 schematically shows a second example of a blood treatmentapparatus;

FIG. 3 schematically shows a third example of a blood treatmentapparatus;

FIG. 4a is a flowchart showing a first embodiment of a control procedureaccording to an aspect of the invention, performable by a control unitof an apparatus, for example of the type shown in FIG. 1;

FIG. 4b is a flowchart showing a second embodiment of the controlprocedure according to an aspect of the invention, performable by acontrol unit of an apparatus, for example of the type shown in FIG. 2;

FIG. 4c is a flowchart showing a third embodiment of a control procedureaccording to an aspect of the invention, performable by a control unitof an apparatus, for example of the type shown in FIG. 1;

FIG. 5 is a chart showing the set point required to keep the desiredblood temperature at the end of the blood return line.

DETAILED DESCRIPTION

FIGS. 1 to 3 show exemplifying, and non limiting, embodiments of anapparatus for extracorporeal treatment of blood. Note that samecomponents are identified by same reference numerals in FIGS. 1 to 3.

FIG. 1 schematically shows a first example of a blood treatmentapparatus 1 designed for delivering any one of the following treatments:hemodialysis, hemofiltration, hemodiafiltration, and ultrafiltration.

The apparatus 1 comprises a treatment unit 2 having a primary chamber 3and a secondary chamber 4 separated by a semipermeable membrane 5.Depending upon the treatment, the semipermeable membrane 5 of thetreatment unit 2 may be selected to have different properties andperformances. A blood withdrawal line 6 is connected to an inlet of theprimary chamber 3, and a blood return line 7 is connected to an outletof the primary chamber 3. The blood withdrawal line 6, the primarychamber 3 and the blood return line 7 are part of an extracorporealblood circuit 100.

In use, an end 60 of the blood withdrawal line 6 is connected to aneedle or to a catheter or other arterial access device (not shown)which is then placed in fluid communication with the vascular system ofa patient P. An end 70 of the blood return line 7 is connected to aneedle or to a catheter or other venous vascular access device (notshown) which is then placed in fluid communication with the vascularsystem of the patient P. Blood can be withdrawn through the bloodwithdrawal line 6, passed through the primary chamber 3 and thenreturned to the patient's vascular system through the blood return line7.

An air separator, such as a bubble trap 8 may be present in the bloodreturn line 7. Moreover, a safety clamp 9 controlled by a control unit10 may be present on the blood return line 7 downstream the bubble trap8. A bubble sensor (not shown), for instance associated with the bubbletrap 8 or coupled to a portion of the line 7 between the bubble trap 8and the safety clamp 9, may be present. If present, the bubble sensor isconnected to the control unit 10 and sends to the control unit 10signals for the control unit 10 to cause closure of the safety clamp 9in case one or more bubbles above certain safety thresholds aredetected.

As shown in FIG. 1, the blood flow rate Q_(BLOOD) through the bloodlines is controlled by a blood pump 11, for instance a peristaltic bloodpump, acting either on the blood withdrawal line 6 (as shown in FIG. 1)or on the blood return line 7. An operator may enter a set value for theblood flow rate Q_(BLOOD) by means of a user interface 12, and thecontrol unit 10, during treatment, may be configured to control theblood pump 11 based on the set blood flow rate. The control unit 10 maycomprise a digital processor (CPU) and memory (or memories), an analogcircuit, or a combination thereof.

Blood flow rate through the extracorporeal blood circuit may bedetermined using a blood flow sensor 30.

An effluent fluid line 13 is connected, at one end, to an outlet of thesecondary chamber 4 and, at another end, to a waste, for instancecomprising an effluent fluid container 14 collecting the fluid extractedfrom the secondary chamber 4 or coming from a drainage line, not shown.The embodiment of FIG. 1 also presents a pre-infusion line 15 having oneend connected to the blood withdrawal line 6. This line 15 suppliesinfusion fluid from an infusion fluid source, such as an infusion fluidcontainer 16, connected at the other end of the pre-infusion line 15.

Note that alternatively or in addition to the pre-infusion line theapparatus 1 of FIG. 1 may include a post-infusion line 25 which may beconnected to the blood return line 7 at a junction point (either at thebubble trap 8 or upstream the bubble trap 8 or even downstream thebubble trap 8 (e.g. upstream safety clamp 9). The post-infusion line 25connects an infusion fluid source, such as a post-infusion fluidcontainer 26 (which for instance may contain a drug, or calcium whenperforming citrate anticoagulation, or a nutrient solution or other), tothe blood return line.

As mentioned, the apparatus 1 of FIG. 1 may include both a pre-infusionline 15 and a post-infusion line 25. In this case, each infusion fluidline may be connected to a respective infusion fluid container 16, 26,or the two infusion fluid lines may receive infusion fluid from a commonsource of infusion fluid such as one and the same infusion fluidcontainer. Additionally, the apparatus 1 may present a further infusionline 21 connected, at one end, with a portion 6 a of the bloodwithdrawal line 6 positioned upstream the blood pump 11 and, at itsother end, with a further infusion fluid container 23, which forinstance may contain a drug, or a regional anticoagulant such as acitrate solution or other. This further infusion line is herein referredto as pre-blood pump infusion line 21. The apparatus 1 of FIG. 1, mayfurther include a treatment (dialysis) fluid line 19 connected at oneend with a treatment (dialysis) fluid container 20 and at its other endwith the inlet of the secondary chamber 4 of the treatment unit 2.

Although the exemplifying apparatus 1 shown in FIG. 1 comprises alllines 13, 19, 15, 21 and 25, this should not be read in a limitativemanner. In fact the apparatus 1 may be of the type having only one ormore of the above described infusion lines 15, 21, 25.

Depending upon the type of apparatus 1, and thus depending upon thenumber and type of lines present, corresponding pumps may be present ornot. An effluent fluid pump 17 operates on the effluent fluid line 13under the control of said control unit 10 to regulate the effluent fluidflow rate Q_(EFF) in the effluent fluid line 13. If the apparatus 1 hasa pre-infusion line 15, then a pre-infusion pump 18 acts on pre-infusionline 15 to regulate the pre-infusion flow rate Q_(REP1) through the samepre-infusion line 15. If the apparatus 1 has a post-infusion line 25,then a post-infusion pump 27 acts on post-infusion line 25 to regulatethe post-infusion flow rate Q_(REP2) through the same post-infusion line25. Note that in case of two infusion lines (pre-infusion 15 andpost-infusion 25) each infusion line may cooperate with a respectiveinfusion pump 18, 27.

In case the apparatus 1 has the treatment fluid line 19, a treatmentfluid pump 28 is active on the treatment fluid line 19 under the controlof said control unit 10, to supply fluid from the treatment fluidcontainer 20 to the secondary chamber 4 at a treatment fluid flow rateQ_(TREAT). In case the pre-blood pump infusion line 21 is present, apre-infusion pump 22, also controlled by control unit 10, may act on asegment of the pre-blood pump infusion line 21 to regulate a pre-bloodpump infusion rate Q_(PBP). The treatment fluid pump 28, thepre-infusion pumps 18, 22, the effluent fluid pump 17 and thepost-infusion pump 27 are operatively connected to the control unit 10which controls the pumps. The pump control may be carried out by thecontrol unit 10 based on set values of desired flow rates through theabove lines as entered by the operator or as pre-stored in a memoryconnected to the control unit 10.

In case the sources of the fluids are containers, such as bags as shownin FIG. 1, then scales 33, 34, 35, 36, 39 may be used to provide weightsignals to the control unit 10 and thus allow the control unit 10 todetermine, e.g. periodically, the actual flow rate through each line 13,15, 19, 21, 25 and regulate the speeds of the pumps accordingly. Notethat flow rate through the above lines or at least the overall weightloss rate may be determined using flow sensors 24 a, 24 b, 24 c, 24 d,24 e different from scales (schematically shown in FIG. 1). Forinstance, Coriolis mass flow sensors, mechanical flow sensors,electromagnetic flow sensors, volumetric flow sensors could be used inorder to detect or allow detection by the control unit 10 of the actualflow rate through each of the above lines. Moreover, instead of usingfluid containers 16, 20, 23, 26 the infusion fluids and/or the treatmentfluid may be produced online by the apparatus 1 and then supplied to theextracorporeal blood circuit (in case of infusion fluids) and to thesecond chamber 4 of the treatment unit 2 (in case of treatment fluid).

Temperature sensors 29 b, 29 d, 29 e, 29 c are also present on theinfusion fluid containers 16, 23, 26 and on the treatment fluidcontainer 20 to provide temperature signals to the control unit 10.

The control unit 10 is also connected to the user interface 12, forinstance a graphic user interface 12, which receives operator's inputsand displays the apparatus outputs. For instance, the graphic userinterface 12 may include a touch screen, a display screen and/or hardkeys for entering operator's inputs or a combination thereof.

With reference to the example of FIG. 1, a warming device 200 isassociated with the apparatus 1 to form an assembly which is structuredto treat blood and keep blood within certain desired temperatureboundaries. The warming device 200 may be an independent device (e.g. astand alone unit physically separated from the apparatus 1) cooperatingwith the apparatus 1 and—in particular—warming a portion of theextracorporeal blood circuit 100. In this case, the warming device 200comprises its own control system 201 and its own power supply system 202which are respectively separate from the power supply and from thecontrol unit 10 of the apparatus 1. The control unit 10 of theextracorporeal blood treatment apparatus 1 is configured to communicatewith the control system 201 of the warming device 200. Alternatively,the warming device 200 may be a component of the apparatus 1: in thiscase the warming device 200 is not an independent stand alone unit, butrather part of the apparatus 1.

In this second alternative, the power supply of the apparatus 1 may alsoserve and be connected to the warming device 200. Moreover, the controlunit 10 directly controls the warming device 200. In particular thecontrol unit 10 may be configured to execute at least two tasks: first,controlling operation of the extracorporeal blood treatment apparatus 1,and, second, controlling operation of the warming device 200.

In both cases, the warming device 200 has a heating unit 203 configuredfor receiving and heating a corresponding heated portion 102 of theextracorporeal blood circuit 100.

For instance, the heated portion 102 of the extracorporeal blood circuit100 may be in the form of a substantially flat bag insertable in aheating seat provided in the heating unit 203 of the warming device 200.The flat bag presents an inlet and an outlet connected to theextracorporeal blood circuit.

Alternatively, the heated portion 102 may include a section of thetubing or a rigid cassette inserted into the heating unit 203 of thewarming device 200, which heating unit 203 for instance may comprise aheating sleeve or a heating coil wound around the heated portion 102. Inpractice the heating unit 203 has heating elements (e.g. electricimpedances, infrared emitters or other types of heating elements)configured to heat the corresponding heated portion 102 of theextracorporeal blood circuit 100.

The warming device 200 may also include a first fluid temperature sensor204 configured for measuring at least a blood temperature at an exit ofthe heating unit 203 and, optionally, a second fluid temperature sensor205 configured for measuring a further blood temperature at an entry tothe heating unit 203. The warming device 200 further includes a powersupply sensor 206 configured for measuring at least an actual electricpower value supplied to (or absorbed by) the heating components of thewarming device 200. Temperature sensor 204, sensor 205 (if present) andpower supply sensor 206 are connected to the control system 201 of theblood warming device 200 or directly to the control unit 10 of theapparatus 1.

As shown in FIG. 1, the warming device 200 is associated with theextracorporeal blood circuit 100 at the blood return line 7, e.g.upstream of the bubble trap 8.

FIG. 2 schematically shows the apparatus 1 of FIG. 1 wherein the warmingdevice 200 is associated with the blood withdrawal line 6 downstream ofthe blood pump 11 and upstream of the treatment unit 2.

FIG. 3 schematically shows the apparatus 1 of FIG. 1 wherein the warmingdevice 200 is associated with the treatment fluid line 19. The heatingunit 203 of the warming device 200 is configured for receiving andheating a corresponding heated portion of the treatment fluid line 19.The first fluid temperature sensor 204 is placed at the outlet of theprimary chamber 3 of the treatment unit 2.

In all the embodiments the warming device 200 is configured to heat(directly or indirectly) a blood heating zone H of the extracorporealblood circuit 100.

In the embodiments of FIGS. 1 and 2, the warming device 200 directlyheats the heated portion 102 of the extracorporeal blood circuit 100. Inthese embodiments, the blood heating zone H therefore coincides with theheated portion 102.

In the embodiment of FIG. 3, the warming device 200 directly heats theheated portion of the treatment fluid line 19, and blood is heated byheat exchanged with the treatment fluid in the treatment unit 2. In thisembodiment the blood heating zone H therefore coincides with the bloodchamber of the treatment unit 2.

The control unit 10 of the apparatus 1 is configured to establish acommunication with said blood warming device 200. The communication mayrely on a wired or a wireless telecommunication system and is configuredsuch as to at least allow the control unit 10 to send commands to theblood warming device 200 or to the blood warming device control system201.

The control unit 10 is configured to perform a procedure in order tocontrol the warming device 200 with the aim of maintaining at a desiredtemperature the blood flowing back to the patient P in presence ofcooling effects mainly caused by infusion of fluids. In other words, thecontrol unit 10 performs a control procedure to keep at a desired valueT_(des) the temperature of blood at the end 70 of the blood return line7. In the context of the present invention, the end 70 of the bloodreturn line 7 which is kept at the desired blood temperature T_(des) isat the venous vascular access device.

FIG. 4a shows a first flowchart of the steps the control unit 10 ofapparatus 1 may be configured to execute, in accordance with a firstembodiment of the procedure with reference to the apparatus 1 of FIG. 1.

Before starting the extracorporeal blood treatment, or alternatively inthe course of the treatment session, a first value representative of thedesired blood temperature T_(des) at the end 70 of the blood return line7 is set. The desired blood temperature T_(des) is such to avoid anyrisk of hypothermia of the patient P under treatment (i.e. it issubstantially equal to the core temperature of the patient P). Thecontrol unit 10 receives such desired blood temperature T_(des).

This first value may be a fixed value (by way of example such firstvalue may be 37.5° C.) stored in the memory of the control unit 10 ormay depend on the patient P under treatment and may be entered by meansof the user interface 12.

During the extracorporeal blood treatment, the control unit 10 receives,from the flow sensor 24 e, a first signal relating to the post-infusionflow rate Q_(REP2) of the infusion fluid in the post-infusion line 25.The control unit 10 receives, from the temperature sensor 29 e, a secondvalue which is representative of the temperature T_(REP2) of theinfusion fluid in said post-infusion line 25. The control unit 10further may receive, from the blood flow sensor 30, a second signalwhich is representative of the blood flow rate Q_(BLOOD) in theextracorporeal blood circuit 100.

Instead of the measured flows, the CPU of the control unit 10 mayreceive the set value of the desired post-infusion flow rate Q_(REP2) ofthe infusion fluid in the post-infusion line 25 and the desired bloodflow rate in the extracorporeal blood circuit 100 which were pre-storedin its memory. Instead of receiving the second value from thetemperature sensor 29 e, the temperature T_(REP2) of the infusion fluidmay be assumed equal to the room temperature and may be inputted in thecontrol unit 10 by an operator by means of the user interface 12.

The control unit 10 calculates a set point value of an operatingparameter to be imposed on the warming device 200 in order to maintainsaid desired blood temperature T_(des) at said end 70 of the bloodreturn line 7.

According to the first embodiment of the procedure, the operatingparameter is the blood temperature T_(OUT) at an outlet of the bloodheating zone H. Referring to FIG. 1, such blood temperature T_(OUT) ismeasured by the first fluid temperature sensor 204 at the exit of theheating unit 203 of the warming device 200.

The control unit 10 calculates the set point (blood temperature T_(OUT)to be kept at the outlet of the blood heating zone H) based on thepost-infusion flow rate Q_(REP2) of the infusion fluid in thepost-infusion line 25, on the temperature T_(REP2) of the infusion fluidin said post-infusion line 25 and on the blood flow rate Q_(BLOOD) inthe extracorporeal blood circuit 100 as input parameters.T _(OUT) =f(Q _(REP2) , T _(REP2) , Q _(BLOOD))

According to a variant of the first embodiment, the set point may becalculated based also on the room temperature T_(ROOM) in order to takeinto account the heat losses to atmosphere in the extracorporeal bloodcircuit 100 downstream of the blood heating zone H (in the apparatus 1of FIG. 1 this means downstream of the warming device 200).T _(OUT) =f(Q _(REP2) , T _(REP2) , Q _(BLOOD) , T _(ROOM))

According to a possible variant of the first embodiment, the set pointmay also be calculated based on blood properties such as one or more inthe group of: blood density, specific heat, hematocrit, total proteinconcentration.

Calculation of the set point of the blood temperature T_(OUT) at anoutlet of the blood heating zone H is performed by the control unit 10by means of a function stored in the memory of said control unit 10interrelating said set point with said input parameters.

The following Equation 1 expresses the temperature T_(btrap) of theblood at the outlet of the bubble trap 8 as a function of the desiredblood temperature T_(des) taking into account the heat losses toatmosphere along the length of the blood return line 7 downstream of thebubble trap 8 and until the patient end 70 of the blood return line 7.

$\begin{matrix}{T_{btrap} = {T_{ROOM} + {( {T_{des} - T_{ROOM}} ) \times \exp^{\frac{p \times {Lret}}{\rho\;{blood} \times {Cpblood} \times {Qbret}}}}}} & {{Eq}{.1}}\end{matrix}$

The following Equation 2 expresses the blood temperature T_(OUT) to bekept at the outlet of the blood heating zone H (at the exit of thewarming device 200) as a function of the temperature T_(btrap) of theblood at the outlet of the bubble trap 8 in the condition where the saidblood temperature T_(OUT) is identical to the warmer set pointtemperature T_(w).

$\begin{matrix}{{{T_{OUT} = {T_{w} = \frac{\begin{matrix}{{\rho_{blood} \times C_{pblood} \times Q_{bret} \times T_{btrap}} -} \\{\rho_{{REP}\; 2} \times C_{p\;{REP}\; 2} \times Q_{{REP}\; 2} \times T_{{REP}\; 2}}\end{matrix}}{\rho_{blood} \times C_{pblood} \times ( {Q_{bret} - Q_{{REP}\; 2}} )}}}{{{with}\mspace{14mu} Q_{bret}} = {Q_{BLOOD} + Q_{{REP}\; 2}}}}\;} & {{Eq}{.2}}\end{matrix}$

List of Variables and Parameters

-   -   C_(pblood): blood specific heat (J/° C./g)    -   C_(pREP2): infusion fluid specific heat (J/° C./g)    -   p: heat loss coefficient to atmosphere for return line (W/°        C./m)    -   L_(ret): length of blood return line downstream the bubble trap        (m)    -   ρ_(blood): blood density (g/ml)    -   ρ_(REP2): infusion fluid density (g/ml    -   Q_(BLOOD): blood flow rate (ml/min)    -   Q_(bret): blood flow rate in the blood return line (ml/min)    -   Q_(REP2): post infusion flow rate (ml/h)    -   T_(ret): blood temperature at the end of blood return line (°        C.)    -   T_(des): desired blood temperature at the end of blood return        line (° C.)    -   T_(btrap): blood temperature at bubble trap outlet (° C.)    -   T_(OUT): blood temperature at the outlet of the blood heating        zone (warmer outlet) (° C.)    -   T_(w): warmer set point temperature    -   T_(ROOM): room temperature (° C.)    -   T_(REP2): infusion fluid temperature (° C.)

The above equations are used with the following values of parameters:

-   ρ_(blood)=1.05 g/ml-   ρ_(REP2)=1.0 g/ml-   C_(pblood)=C_(pREP2)=C_(pwater)=4.18 J/° C./g-   T_(ROOM)=TREP2=24° C.-   L_(ret)=2.10 m-   p=0.38 W/° C./m

The desired blood temperature T_(des) at the end of the blood returnline 7 is set equal to 37° C.

The following table shows the set point of the blood temperature T_(OUT)calculated with Eq.1 and Eq.2 for a plurality blood flow rates Q_(BLOOD)and post infusion flow rates Q_(REP2).

TABLE 1 Condition 1 2 3 4 5 6 Q_(BLOOD) 100 100 200 200 300 300 (ml/min)Q_(REP2) 800 1500 800 2500 800 3500 (ml/h) T_(btrap) 38.53 38.53 37.7437.74 37.48 37.48 (° C.) T_(OUT) = 40.98 43.87 38.80 41.69 38.17 41.04T_(w) (° C.)

Since the operating parameter is the blood temperature T_(OUT)downstream of the warming device 200, all the heat losses upstream ofthe warming device 200 (caused mainly by the infusion fluids from thepre-infusion lines 15, 21 and by the treatment fluid in the treatmentunit 2) need not to be taken into account in the above formula in orderto calculate the set point. It follows that all the temperature sensors29 b, 29 d, 29 c and flow sensors 24 a, 24 b, 24 c, 24 d upstream of theblood heating zone H may also not be present for this purpose.

Referring now to the apparatus 1 of FIG. 3, it is noted that the firstfluid temperature sensor 204 is placed at the outlet of the treatmentunit 2, i.e. immediately downstream of the heating zone H which in thiscase is represented by the blood compartment or primary chamber 3 of thetreatment unit 2; therefore the control unit 10 of the apparatus 1 ofFIG. 1 may be configured to execute the procedure according the firstembodiment (flow chart of the procedure is shown in FIG. 4a ) as abovedescribed.

Concerning the apparatus of FIG. 2, the warming device 200 is placed onthe blood withdrawal line 6 and downstream of the pre-infusion line 15;under these circumstances, the input parameters received by the controlunit 10 are:

-   -   from the flow sensor 24 e a first signal relating to the        post-infusion flow rate Q_(REP2) of the infusion fluid in the        post-infusion line 25;    -   from the temperature sensor 29 e a second value which is        representative of the temperature T_(REP2) of the infusion fluid        in the post-infusion line 25;    -   from the flow sensor 24 c, a third signal relating to a flow        rate Q_(TREAT) of a treatment fluid in the treatment fluid line        19;    -   from the temperature sensor 29 c, a third value representative        of a temperature T_(TREAT) of said treatment fluid in said        treatment fluid line 19;    -   from the blood flow sensor 30, a second signal which is        representative of the blood flow rate Q_(BLOOD) in the        extracorporeal blood circuit 100;    -   the room temperature T_(ROOM).

In this way the computation of the set point of the blood temperatureT_(OUT) shall consider:

-   -   the cooling effect from infusion fluids downstream of the        warming device 200;    -   the cooling effect of dialysate, involving a model of the heat        exchange between blood and dialysate in the treatment unit 2;    -   heat losses to atmosphere in the extracorporeal blood circuit        100 downstream the warming device 200. T_(ROOM) is used to take        into account the heat losses to atmosphere downstream of the        warming device 200 including the treatment unit 2.

Thus, for the apparatus of FIG. 2, the control unit 10 may be configuredto calculate the set point of the blood temperature T_(OUT) using thefollowing general formula:T _(OUT) =f(Q _(REP2) , T _(REP2) , Q _(TREAT) , T _(TREAT) , Q _(BLOOD), T _(ROOM))

Please note that, although it is possible to estimate the cooling effectof dialysate without any knowledge of the characteristics of the filterof the treatment unit 2, more accurate computations are possible whenthese filter characteristics are taken into consideration.

In all the three apparatuses of FIGS. 1, 2 and 3, and according to thefirst embodiment of the procedure, the control unit 10 is configured togenerate a control signal comprising a command directed to impose to thewarming device 200 to operate with said operating parameter at thecalculated set point.

The control unit 10 communicates the set point (blood temperatureT_(OUT) at the exit of the warming device 200) to the control system 201of said warming device 200. The control system 201 receives from thefirst fluid temperature sensor 204 also a measured blood temperatureT_(OUT) at the exit of the warming device 200.

The control system 201 adjusts the electric power fed to the heatingunit 203 of the warming device 200 based on said measured bloodtemperature T_(OUT) at the exit of the warming device 200 and on saidcalculated set point in order to keep the measured blood temperatureT_(OUT) at the set point.

When the measured blood temperature T_(OUT) at the exit of the warmingdevice 200 corresponds to the set point, then the blood temperature atthe end 70 of the blood return line 7 is the desired temperatureT_(des).

FIG. 5 shows the blood temperature T_(OUT) to be maintained at the exitof the warming device 200 as function of the post-infusion flow rateQ_(REP2) in the post-infusion line 25 to keep the desired bloodtemperature T_(des) at the target value of 37.5° C. when said targetvalue has to be obtained at the outlet of the bubble trap 8 (please notethat in this example the heat losses to atmosphere due to the lengthL_(ret) of the blood return line 7 downstream of the bubble trap 8 havebeen neglected) and when the temperature T_(REP2) of the infusion fluidis 24° C. Note that each straight line corresponds to a respective bloodflow rate Q_(BLOOD). For a given post-infusion flow rate Q_(REP2), ifthe blood flow rate Q_(BLOOD) increases, the blood temperature T_(OUT)at the exit of the warming device 200 required to keep the target valuedecreases.

In the following table (table 2) the post-infusion flow rate Q_(REP2) isequal to 2000 ml/h.

TABLE 2 Q_(BLOOD) (ml/min) T_(OUT) (° C.) 100 42 150 40.5 200 39.7 25039.3 350 38.8

In a second embodiment of the procedure, which may be adopted with theapparatuses of FIG. 1 or FIG. 2, the first fluid temperature sensor 204is not present and the operating parameter is the electric power P_(w)supplied to the heating unit 203 of the warming device 200 or anotherparameter linked to said power, such as a working temperature of saidwarming device 200 (by way of example, the heating plate temperature ina heating plates warming device).

In this case, the input parameters received by the control unit 10 are:

-   -   from the second fluid temperature sensor 205, the blood        temperature T_(IN) at the entry of the warming device 200;    -   from the flow sensor 24 e, a first signal relating to the        post-infusion flow rate Q_(REP2) of the infusion fluid in the        post-infusion line 25;    -   from the temperature sensor 29 e, a second value which is        representative of the temperature T_(REP2) of the infusion fluid        in said post-infusion line 25;    -   from the blood flow sensor 30, a second signal which is        representative of the blood flow rate Q_(BLOOD) in the        extracorporeal blood circuit 100;    -   the room temperature T_(ROOM).        P _(w) =f(T _(IN) , Q _(REP2) , T _(REP2) , Q _(BLOOD) , T        _(ROOM))

The control unit 10 calculates the set point (electric power P_(w) whichhas to be supplied to the heating unit 203) based on the post-infusionflow rate Q_(REP2) of the infusion fluid in the post-infusion line 25,on the temperature T_(REP2) of the infusion fluid in said post-infusionline 25 and on the blood flow rate Q_(BLOOD) in the extracorporeal bloodcircuit 100 as input parameters and on the blood temperature T_(IN) atthe entry of the warming device 200. T_(ROOM) is used to take intoaccount the heat losses to atmosphere in the length of tubing downstreamof the warming device 200.

Calculation of the set point is performed by the control unit 10 bymeans of a function stored in the memory of said control unit 10interrelating said set point with said input parameters.

Since the operating parameter is the electric power P_(w) supplied tothe heating unit 203, and the blood temperature just upstream of thewarming device 200 is known, all the heat losses upstream of the warmingdevice 200 (caused mainly by the infusion fluids from the pre-infusionlines 15, 21 and by the treatment fluid in the treatment unit 2) neednot to be taken into account in order to calculate the set point.

As far as the apparatus 1 of FIG. 2 is concerned, the warming device 200is placed on the blood withdrawal line 6 and downstream of thepre-infusion line 15.

FIG. 4b shows a second flowchart of the steps the control unit 10 ofapparatus 1 may be configured to execute, in accordance with the secondembodiment of the procedure with reference to the apparatus 1 of FIG. 2.

The input parameters received by the control unit 10 in accordance withthe second embodiment procedure are:

-   -   from the second fluid temperature sensor 205, the blood        temperature T_(IN) at the entry of the warming device 200;    -   from the flow sensor 24 e a first signal relating to the        post-infusion flow rate Q_(REP2) of the infusion fluid in the        post-infusion line 25;    -   from the temperature sensor 29 e a second value which is        representative of the temperature T_(REP2) of the infusion fluid        in the post-infusion line 25;    -   from the flow sensor 24 c, a third signal relating to a flow        rate Q_(TREAT) of a treatment fluid in the treatment fluid line        19;    -   from the temperature sensor 29 c, a third value representative        of a temperature T_(TREAT) of said treatment fluid in said        treatment fluid line 19;    -   from the respective blood flow sensor 30, a second signal which        is representative of the blood flow rate Q_(BLOOD) in the        extracorporeal blood circuit 100;    -   the room temperature T_(ROOM).

In this way the computation of the set point T_(OUT) shall consider:

-   -   the cooling effect from infusion fluids downstream of the        warming device 200;    -   the cooling effect of dialysate, involving a model of the heat        exchange between blood and dialysate in the treatment unit 2;    -   heat losses to atmosphere in the extracorporeal blood circuit        100 downstream the warming device 200. T_(ROOM) is used to take        into account the heat losses to atmosphere downstream of the        warming device 200 including the treatment unit 2.        P _(w) =f(T _(IN) , Q _(REP2) , T _(REP2) , Q _(BLOOD) , T        _(TREAT) , Q _(TREAT) , T _(ROOM))

The control unit 10 communicates the set point (electric power P_(w)) tothe control system 201 of said warming device 200. The control system201 adjusts the electric power fed to the heating unit 203 of thewarming device 200 in order to keep it at the set point.

When the electric power P_(w) corresponds to the set point, then theblood temperature at the end 70 of the blood return line 7 is thedesired blood temperature T_(des).

In a third embodiment of the procedure with the apparatus 1 of FIG. 1,the operating parameter is always the electric power PW but thetemperature at the entry of the warming device 200 is unknown (as thereis no second fluid temperature sensor 205 at the entry of the warmingdevice 200).

FIG. 4c shows a third flowchart of the steps the control unit 10 ofapparatus 1 may be configured to execute, in accordance with the thirdembodiment of the procedure with reference to the apparatus 1 of FIG. 1.

The input parameters received by the control unit 10 in accordance withthe procedure of the third embodiment are:

-   -   from the respective flow sensors 24 e, 24 b, 24 d, first signals        relating to the post-infusion flow rate Q_(REP2) of the infusion        fluid in the post-infusion line 25, the pre-infusion flow rate        Q_(REP1) of the infusion fluid in the pre-infusion line 15, the        flow rate Q_(PBD) of the infusion fluid in the pre-blood pump        infusion line 21;    -   from the respective temperature sensors 29 e, 29 b, 29 d, second        values which are representative of the temperature T_(REP2) of        the infusion fluid in the post-infusion line 25, the temperature        T_(REP1) of the infusion fluid in the pre-infusion line 15, the        temperature T_(PBD) of the infusion fluid in the pre-blood pump        infusion line 21;    -   from the flow sensor 24 c, a third signal relating to a flow        rate Q_(TREAT) of a treatment fluid in the treatment fluid line        19;    -   from the temperature sensor 29 c, a third value representative        of a temperature T_(TREAT) of said treatment fluid in said        treatment fluid line 19;    -   from the blood flow sensor 30, a second signal which is        representative of the blood flow rate Q_(BLOOD) in the        extracorporeal blood circuit 100;    -   the temperature T_(PATIENT) of blood at the end 60 of the blood        withdrawal line 6 (which is the core temperature of the patient        P and may be set at about 37.5° C.)    -   the room temperature T_(ROOM).        P _(w) =f(Q _(REP1) , Q _(REP2) , T _(REP1) , T _(REP2) , Q        _(PBD) , T _(PBD) , Q _(TREAT) , T _(TREAT) , Q _(BLOOD) , T        _(PATIENT) , T _(ROOM))

The control unit 10 calculates the set point (electric power to besupplied to the heating unit 203 of the warming device 200) based onsaid input parameters. T_(ROOM) is used to take into account the heatlosses to atmosphere in the length of tubing downstream of the warmingdevice 200.

Calculation of the set point is performed by the control unit 10 bymeans of a function stored in the memory of said control unit 10interrelating said set point with said input parameters.

Since the temperature at the entry of the warming device 200 is unknownand since the operating parameter (power provided by the warming device200) is related to the amount of heat delivered to the blood at theheating zone H, all the heat losses upstream and downstream of thewarming device 200 and also the blood temperature T_(PATIENT) at the end60 of the blood withdrawal line 6 (which is the core temperature of thepatient P) should be taken into account in order to calculate the setpoint which provides the desired blood temperature T_(des) at the end 70of the blood return line 7.

As a general rule, if a blood temperature sensor in the blood treatmentcircuit is present, the calculation may be independent of what happensupstream of said blood temperature sensor.

The apparatus 1 may further comprise a communication device 300connected to the control unit 10. The communication device 300 may alsobe part of the user interface 12. By means of the communication device300, data from the control unit 10 and/or from the control system 201 ofthe warming device 200 may be communicated to the operator.

The control unit 10 may be configured to communicate by means of saidcommunication device 300 the set point to the operator.

If the warming device 200 is a component of the apparatus 1 and thewarming device 200 is connected to the control unit 10, the control unit10 directly controls the warming device 200 and the set point may bedisplayed by the communication device 300. The control unit 10recalculates the set point either periodically or when a change to atleast one of the input parameters occurs and, if a new set point iscalculated, automatically sends a command directed to impose to thewarming device 200 to operate with said operating parameter at the newset point.

For instance, if infusion in one or more of the infusion lines 15, 21,25 is stopped (e.g. in order to change an infusion fluid container 16,23, 26), the control unit 10 reduces the set point in order to keep thedesired blood temperature T_(des).

According to an embodiment of the apparatus 1 in which the warmingdevice 200 is not connected to the control unit 10 (e.g. because thewarming device 200 is an independent device with respect to theapparatus 1), the set point calculated by the control unit 10 isdisplayed to the operator and the operator inputs said set point intothe warming device 200 (e.g. by means of a user interface, not shown, ofthe warming device 200). The control unit 10 recalculates the set pointeither periodically or when a change to at least one of the inputparameters occurs and, if a new set point is calculated, warns theoperator (e.g. by means of an a visual and/or acoustic signal) to inputsaid new set point into the warming device 200.

According to a variant of the apparatus 1 in which the warming device200 is not connected to the control unit 10, the control unit 10 maywarn the operator also in case of stop of one or more of the infusionfluids.

The control unit 10 may be further configured to take into account amaximum set point in order to prevent patient P over-warming and/or anyblood damage. This maximum set point could be exceeded if, for instance,the operator makes a mistake when inputting the set point into thewarming device 200 or in case of prolonged stop of infusion (if thewarming device 200 is not controlled by the control unit 10). Thismaximum set point could also be exceeded in case of failure of one ormore sensors (even if the control unit 10 controls the warming device200).

In particular, the control unit 10 may be configured to receive themaximum set point (e.g. set by the operator by means of the userinterface 12) and to compare the calculated set point with the maximumset point.

The maximum set point may be a function of the weight of the patient Pand/or of flow settings. In this case, the control unit 10 computes alsothe maximum set point.

If the calculated set point exceeds the maximum set point and thewarming device 200 is controlled by the control unit 10, said controlunit 10 automatically sends a command directed to impose to the warmingdevice 200 to operate with said operating parameter at the maximum setpoint.

If the calculated set point exceeds the maximum set point and thewarming device 200 is not controlled by the control unit 10, saidcontrol unit 10 is configured to send a warning message (e.g. a visualand/or acoustic signal) to the operator by means of the communicationdevice 300.

While the invention has been described in connection with what ispresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andthe scope of the appended claims.

The invention claimed is:
 1. An extracorporeal blood treatmentapparatus, comprising: an extracorporeal blood circuit having atreatment unit, a blood withdrawal line connected to a blood inlet ofthe treatment unit, and a blood return line connected to a blood outletof the treatment unit; a blood pump configured for controlling bloodflow rate flowing through at least one of said blood withdrawal line andblood return line; an infusion line connected to the extracorporealblood circuit; a warming device configured to heat a blood heating zoneof the extracorporeal blood circuit; a control unit configured toexecute the following procedure: receiving a first value representativeof a desired blood temperature at an end of the blood return line,wherein the end of the blood return line is configured to be connectedto a venous vascular access of a patient; receiving a first signalrelating to a flow rate of an infusion fluid in said infusion line;calculating a set point of an operating parameter to be imposed on thewarming device configured to heat the blood heating zone of theextracorporeal blood circuit in order to maintain said desired bloodtemperature at said end of the blood return line; wherein the set pointis calculated based on input parameters comprising: at least the firstvalue representative of the desired blood temperature and at least oneof: the first signal and a second value representative of a temperatureof said infusion fluid in said infusion line; wherein the warming deviceis located on the blood return line or on the blood withdrawal line andconfigured to directly heat the blood heating zone.
 2. Apparatusaccording to claim 1, wherein the control unit is further configured to:receive a second signal relating to the blood flow rate in theextracorporeal blood circuit; wherein the input parameters comprise saidsecond signal.
 3. Apparatus according to claim 1, wherein the infusionline is connected to the extracorporeal blood circuit at a junctionpoint which is positioned downstream of the blood heating zone betweenthe blood heating zone and said end of the blood return line. 4.Apparatus according to claim 1, comprising a treatment fluid lineconnected to the treatment unit, wherein the control unit is furtherconfigured to: receive a third signal relating to a treatment fluid flowrate in said treatment fluid line; receive a third value representativeof a temperature of said treatment fluid in said treatment fluid line;wherein the input parameters also comprise the third signal and thethird value representative of the temperature of the treatment fluid. 5.Apparatus according to claim 4, wherein the infusion line comprises oneinfusion line of a plurality of infusion lines connected to theextracorporeal blood circuit and the first signal comprises one firstsignal of a plurality of first signals, wherein each first signal of theplurality of first signals relates to a flow rate of an infusion fluidin one infusion line of the plurality of infusion lines; wherein thecontrol unit is configured to receive the plurality of first signals andto calculate said set point based on the following input parameters: oneor more first signals of the plurality of first signals, and one or moretemperatures of the infusion fluid in one or more infusion lines of theplurality of infusion lines connected to the extracorporeal bloodcircuit downstream of the blood heating zone.
 6. Apparatus or assemblyaccording to claim 4, wherein one or more infusion lines of theplurality of infusion lines are connected to the extracorporeal bloodcircuit upstream of the blood heating zone, and wherein the inputparameters further comprise: one or more first signals of the pluralityof first signals relating to a flow rate of the infusion fluid in theone or more infusion lines connected to the extracorporeal blood circuitupstream of the blood heating zone, and one or more temperatures of theinfusion fluid in the one or more infusion lines connected to theextracorporeal blood circuit upstream of the blood heating zone. 7.Apparatus according to claim 1, wherein the warming device has a heatingunit configured for receiving and heating a corresponding heated portionof the extracorporeal blood circuit.
 8. Apparatus according to claim 1,wherein the infusion line comprises at least one of: a post-infusionline directly connected to said blood return line; a pre-infusion linedirectly connected to said blood withdrawal line downstream of saidblood pump; a pre-blood pump infusion line directly connected to saidblood withdrawal line upstream of said blood pump.
 9. Apparatusaccording to claim 1, wherein the blood heating zone is a portion of theextracorporeal blood circuit positioned on the blood return line. 10.Apparatus according to claim 1, wherein the extracorporeal blood circuitincludes a heated portion, the warming device having a heating unitconfigured for receiving and heating the corresponding heated portion ofthe extracorporeal blood circuit, the heated portion of theextracorporeal blood circuit being in the form of a substantially flatbag insertable in a heating seat provided in the heating unit of thewarming device, the flat bag presenting an inlet and an outlet connectedto the extracorporeal blood circuit.
 11. Apparatus according to claim 1,wherein the warming device is connected to the control unit and thecontrol unit is configured to generate a control signal comprising acommand configured to cause the warming device to operate with saidoperating parameter at the calculated set point.
 12. Apparatus accordingto claim 1, comprising a fluid temperature sensor configured to measurea blood temperature at the outlet of the blood heating zone and to issuea corresponding measurement signal; wherein the operating parameter isthe blood temperature at the outlet of the blood heating zone; whereinthe control unit is configured to perform a feedback control on thewarming device, said feedback control comprising regulating electricpower fed to a heating unit of the warming device or regulating atemperature of a part of the warming device based on a said measurementsignal and on said calculated set point.
 13. Assembly including: anextracorporeal blood treatment apparatus, comprising: an extracorporealblood circuit having a treatment unit, a blood withdrawal line connectedto a blood inlet of the treatment unit, and a blood return lineconnected to a blood outlet of the treatment unit; a blood pumpconfigured for controlling blood flow rate flowing through at least oneof said blood withdrawal line and blood return line; an infusion lineconnected to the extracorporeal blood circuit; a control unit configuredto execute the following procedure: receiving a first valuerepresentative of a desired blood temperature at an end of the bloodreturn line configured to be connected to a venous vascular access of apatient; receiving at least a first signal relating to at least a flowrate of an infusion fluid in said infusion line; calculating a set pointvalue of an operating parameter to be imposed on the warming deviceconfigured to heat the blood heating zone of the extracorporeal bloodcircuit in order to maintain said desired blood temperature at said endof the blood return line, wherein the set point is calculated based oninput parameters comprising: at least the first value representative ofthe desired blood temperature and at least one selected in the group of: the first signal and  a second value representative of a temperature ofsaid infusion fluid in said infusion line; a warming device configuredto heat a blood heating zone of the extracorporeal blood circuit;wherein the warming device and the extracorporeal blood treatmentapparatus are separate, the warming device comprising a warming devicecontrol system separate from the apparatus control unit, wherein thewarming device is located on the blood return line or on the bloodwithdrawal line and configured to directly heat the blood heating zone.14. Assembly according to claim 13, wherein the control unit is furtherconfigured to receive a second signal relating to the blood flow rate inthe extracorporeal blood circuit; wherein the input parameters comprisesaid second signal.
 15. Assembly according to claim 13, wherein theinfusion line is connected to the extracorporeal blood circuit at ajunction point which is positioned downstream of the blood heating zonebetween the blood heating zone and said end of the blood return line.16. Assembly according to claim 13, wherein the extracorporeal bloodcircuit includes a heated portion, the warming device having a heatingunit configured for receiving and heating the corresponding heatedportion of the extracorporeal blood circuit, the heated portion of theextracorporeal blood circuit being in the form of a substantially flatbag insertable in a heating seat provided in the heating unit of thewarming device, the flat bag presenting an inlet and an outlet connectedto the extracorporeal blood circuit.
 17. Assembly according to claim 13,comprising a fluid temperature sensor configured to measure a bloodtemperature at the outlet of the blood heating zone and to issue acorresponding measurement signal; wherein the operating parameter is theblood temperature at the outlet of the blood heating zone; wherein thecontrol unit is configured to perform a feedback control on the warmingdevice, said feedback control comprising regulating electric power fedto a heating unit of the warming device or regulating a temperature of apart of the warming device based on a said measurement signal and onsaid calculated set point.
 18. Assembly according to claim 13, whereinthe warming device control system is configured to receive a controlsignal from the control unit, the control signal comprising a commandconfigured to cause the warming device to operate with said operatingparameter at the calculated set point.
 19. Assembly according to claim13, wherein the apparatus comprises a communication device configured tocommunicate the calculated set point value to an operator; wherein thewarming device control system is configured to receive said calculatedset point and to cause the warming device to operate with said operatingparameter at the calculated set point.
 20. Assembly according to claim13, wherein the warming device comprises a fluid temperature sensorconfigured to measure a blood temperature at the outlet of the bloodheating zone and to issue a corresponding measurement signal; whereinthe operating parameter is the blood temperature at the outlet of theblood heating zone; wherein the warming device control system isconfigured to perform a feedback control, said feedback controlcomprising regulating electric power fed to a heating unit of thewarming device based on said measurement signal and on said calculatedset point imposed by said command.